Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups, Sterile, Disposable, Single Use, For Usage***, Rx Only, Distributed by American Red Cross Blood Services, Washington, DC 20006, Manufactured by: Medimop Medical Projects Ltd, for OMRIX biopharmaceuticals, Utd, MDA blood bank, Sheba Hospital, Romat-Gan, PO8 888, Kiryat Ono 55000 Israel
Hazard
5 mL Crosseal fibrin sealant (human) is difficult to expel from the device resulting in product leakage from the vial insertion port .
What You Should Do
Remedy
American Red Cross was notified of the recall on July 25, 2004. Recall letter to the ARC direct accounts was sent out on 8/9/2004.
Affected by this recall?
Get a free legal consultation about this recall.
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Products
Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups, Sterile, Disposable, Single Use, For Usage***, Rx Only, Distributed by American Red Cross Blood Services, Washington,
- Brand
- Omrix Biopharmaceuticals, Ltd. Plasma Fract. Inst. Magen David Adom Blood Services Ctr., Sheba Hospital Ramat Gan Israel
- UPC
- Lot 0404 exp. Oct. 2008; Lot 0417 exp. Jan. 2009; Lot 0419 exp. Jan. 2009.